Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

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Subjects are randomized to receive a standard induction regimen of adalimumab. After the induction regimen is provided, subjects in this arm will receive blinded adalimumab until Week 12. No placebo arm is planned.

Drug: Adalimumab

Other Name: Humira

Arm 2 Maintenance

Subjects are re-randomized at Week 14 to the therapeutic drug monitoring regimen.

Drug: Adalimumab

Other Name: Humira

Arm 1 - Induction

Subjects are randomized to receive a higher induction regimen of adalimumab. After the induction regimen is provided, subjects in this arm will receive blinded adalimumab until Week 12. No placebo arm is planned.

Drug: Adalimumab

Other Name: Humira

Arm 1 Maintenance

Subjects are re-randomized at Week 14 to a clinically adjusted regimen.

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Ages Eligible for Study:

18 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

Access Criteria:

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.